FDA Policy/General
The House and Senate have approved a bill that provides funding for FDA and other government agencies until 12/8, as well as emergency disaster funding for damage caused by hurricanes Harvey and Irma. The legislation is now being sent to the president for his signature. While the FY 2018
FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2018 public workshop entitled “Self-Collection Devices for Pap Test” that will obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and least burdensome validation approaches for self-collection devices for cervical samples for cervical cancer screening
Drugs
A new study in The BMJ found an association between expedited drug development and review pathways and the likelihood of subsequent safety-related labeling changes. “Further research is required to understand the underlying process factors contributing to the differential rates in safety changes that were observed in this analysis,” the
Devices
FDA has cleared a Spinal Resources 510(k) for its Swedge Pedicle Screw System. The device offers cobalt-chromium and titanium tulips, double lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws, and minimally invasive spinal surgery options, according to the company. Currently, it is cleared for a
Drugs
Daiichi Sankyo says that FDA should deny without delay a Pharmaceutical Manufacturing Research Services (PMRS) petition calling for the agency to stay the effective date for the 4/20 approval of Daiichi’s RoxyBond (oxycodone hydrochloride) immediate-release tablets submitted by Inspirion Delivery Sciences. The Daiichi response says the PMRS
Drugs
Verastem is reporting positive top-line results from its Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase-delta and P13K-gamma in patients with relapsed or refractory chronic lymphatic leukemia/small lymphocytic lymphoma (CLL/SLL). A
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271.” The document provides establishments that manufacture such products with recommendations
Drugs
United Therapeutics has submitted its fourth petition to FDA since 1/14/16 “to ensure that proposed generic treprostinil inhalation solution products meet the same high standards of quality as United Therapeutics’ brand-name product Tyvaso (treprostinil) inhalation solution.” FDA denied the previous three petitions without comment on whether it
Drugs
FDA says that Genentech is recalling to the hospital level three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. An agency statement says that the vials of sterile water for injection manufactured by Pfizer’s Hospira unit and packaged with Activase 100
Drugs
FDA concerns about PD-1/PD-L1 inhibitors have spread to clinical trials conducted by AstraZeneca and Celgene, with clinical holds ordered on their new development program. Last week, CDER director Janet Woodcock said the agency was stepping up its safety surveillance on PD-1/PD-L1 inhibitors after an
FDA Policy/General
FDA deputy commissioner for policy, planning, legislation, and analysis Anna Abram says the agency is looking for feedback from many stakeholders as it reviews more than 4,000 pages of agency regulations in the Code of Federal Regulations to see how they can be modernized, revised, updated, or eliminated. Writing
Drugs
Researchers in CDER’s Office of Biotechnology Products (OBP) are studying chemical reactions that occur in therapeutic protein products and can have a significant impact on protein function. CDER laboratory of biochemistry chief V. Ashutosh Rao writes in a Spotlight on CDER Science post that the chemical reactions are of
Drugs
Three FDAers write in an online Nature comment that since approval of the Orphan Drug Act in 1983, the agency has approved more than 600 orphan drug indications. The article discusses three key issues for maintaining that approval trajectory for rare disease therapies: * a science-based rationale for granting orphan
Drugs
A 2/20-3/24 FDA inspection at Pfizer’s Meridian Medical Technologies manufacturing facility in Brentwood, MO, which holds a contract to produce EpiPen and EpiPen Jr. for Mylan, found significant violations of current good manufacturing practice (CGMP) requirements for combination products, according to a 9/5 Warning Letter
FDA Policy/General
Federal Register notice: FDA has announced a 10/30 public workshop entitled “CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development” that is intended to help the rare disease community to understand what the agency needs to enhance drug development. It
Drugs
FDA is planning to revamp its early pre-clinical involvement with medical product developers as part of a new “Strategic Policy Roadmap” that will be unveiled soon, commissioner Scott Gottlieb told an online Research America 2017 National Health Research Forum in Washington, DC 9/7. New policies are being formulated
Devices
FDA has cleared an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache. The prescription-only device uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain, according to the company. It says
Devices
A Minnesota federal court has dismissed a whistleblower’s fraud on FDA claims against Boston Scientific Corp., but will allow him to re-file the allegations with greater particularity. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the case involves two of
Drugs
The Justice Department says Novo Nordisk will pay $58.65 million to resolve allegations brought by whistleblowers that the company failed to comply with an FDA-mandated REMS (risk evaluation and mitigation strategy) for its Type 2 diabetes drug Victoza (liraglutide). A department statement says the resolution includes disgorgement of
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The document is intended to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use
Drugs
FDA has released the FDA-483 issued following a 5/22-6/2 inspection at Celltrion, an Inchon, Korea, sterile injectable drug product and drug substance manufacturer. The form lists the inspection observations as: * failing to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
Drugs
FDA says it is recommending an increase in dosing of Grifols Therapeutics’ GamaSTAN S/D (immune globulin [human]) when used for hepatitis A (HAV) prophylaxis. An agency notice says the dosage increase is based on recently observed decreasing concentrations of antibodies to hepatitis A in GamaSTAN S/D attributed to